Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial
Recruiting
Phase 3
Interventional Study
Obstetrical Complications
Labor and Delivery Complication
Cesarean Delivery
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 8,000 (estimated)
- Sponsor
- The George Washington University Biostatistics Center · Other
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About This Trial
This is a phase-III multi-center double-blind randomized controlled trial of 8,000 individuals undergoing a scheduled or prelabor cesarean delivery who are randomized to either adjunctive azithromycin prophylaxis or to placebo. Both groups also will receive standard of care preoperative antibiotics (excluding azithromycin). The primary endpoint is a maternal infection composite defined as any one …
Trial Locations
Sorted by distance from Kentucky
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Eligibility Criteria
Inclusion Criteria:
* ≥ 23 weeks' gestation (ACOG dating criteria)
* Scheduled or prelabor cesarean delivery
* Singleton or twin gestation
Exclusion Criteria:
* Allergy or contraindication to azithromycin or macrolide antibiotics, including those with a history of cholestatic jaundice/hepatic dys…
Contacts